Protocol summary

Study aim
• To identify the Effect of Sustained Natural Apophyseal Glide With And Without Neurodynamics In The Management Of Patient With Cervical Radiculopathy.
Design
Interventional study Randomized Clinical Trial Non propability convience sampling techenique
Settings and conduct
Sample size will be 44 individuals (22 each group) Conducted in time duration of 6 months
Participants/Inclusion and exclusion criteria
Inclusion Criteria 1. Patients having Age 22-40 years 2. Both genders 3. Patient availability and cooperation during treatment 4. Patients with positive result of following tests:Spurling test,ULNT-1,neck distraction and ipsilateral cervical rotation test. Exclusion Criteria 1. Patients having negative one of the following tests:Spurling test,ULNT-1,neck distraction and ipsilateral cervical rotation test. 2. Patients with accessory Systemic Musculoskeletal Dysfunction 3. Patients having symptoms of Vertebral Artery Insufficiency. 4. Patients not willing to participate or to follow up treatment plan.
Intervention groups
There will be two groups of equal number of individuals diagnosed with cervical radiculopathy after confirmation of Manual tests. Group A Control group will receive Sustained Natural Apophyseal Glide only. Patients in this group will receive a baseline treatment that is heating pad for 15 minutes before the treatment. Group B. This group will receive Sustained Natural Apophyseal Glide along with Neurodynamics. Patients in this group will receive a baseline treatment that is heating pad for 15 minutes before the treatment.
Main outcome variables
Correcting Cervical Radiculopathy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191023045218N1
Registration date: 2020-01-04, 1398/10/14
Registration timing: prospective

Last update: 2020-01-04, 1398/10/14
Update count: 0
Registration date
2020-01-04, 1398/10/14
Registrant information
Name
Shehnila Shoukat
Name of organization / entity
Riphah international University
Country
Pakistan
Phone
+92 454 710161
Email address
shehnila.499@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-09-23, 2019/07/01
Expected recruitment end date
2640-11-22, 2019/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Sustained Natural Apophyseal Glide with and Without Neurodynamics in the Management of Patient with Cervical Radiculopathy
Public title
Management of Patient with Cervical Radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients having Age 22-40 years Both genders Patients with positive result of following tests:Spurling test,ULNT-1,neck distraction and ipsilateral cervical rotation test. Patient availability and cooperation during treatment
Exclusion criteria:
Patients having negative one of the following tests:Spurling test,ULNT-1,neck distraction and ipsilateral cervical rotation test. Patients with accessory Systemic Musculoskeletal Dysfunction Patients having symptoms of Vertebral Artery Insufficiency. Patients not willing to participate or to follow up treatment plan.
Age
From 22 years old to 40 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Simple method, individual unit of randomization, table of random numbers, allocation with concealment, Non-Probability Convenience Sampling
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were blinded as they don't know their respected group, therapist who gave treatment and assess the outcome was blinded.
Placebo
Not used
Assignment
Parallel
Other design features
44 number of individuals divided in 2 equal groups of 22 individuals.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Riphah college of Rehablitation Sciences
Street address
House No.4292,Street No.2,MohaAllah Ali Pura Khushab
City
Khushab
Postal code
41000
Approval date
2640-09-29, 2019/07/07
Ethics committee reference number
RCRS-RE-MS-OMPT/Spring 19/023

Health conditions studied

1

Description of health condition studied
Cervical radiculopathy (CR) is a pathological condition of the cervical nerve root (CNR) that may lead to chronic pain and disability.Cervical radiculopathy is known to be a neurological problem with its associated symptoms like pain, numbness, muscle weakness and diminished reflexes in one or both upper extremities and if prolongs these symptoms lead to headache, functional impairment, activity limitation and difficulty to return to work. Other leading causes of CR are cervical disc hernia ion with and without formation of spur and cervical spondylosis accompanied by inflammation and nerve compression due to dehydration and eventually collapsing of cervical discs.
ICD-10 code
M50.10
ICD-10 code description
Cervical disc disorder with radiculopathy, unspecified cervical region

Primary outcomes

1

Description
Correcting Cervical Radiculopathy
Timepoint
6 months
Method of measurement
Data collection tools

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Control group will receive Sustained Natural Apophyseal Glide only. Patients in this group will receive a baseline treatment that is heating pad for 15 minutes before the treatment.
Category
Rehabilitation

2

Description
Intervention group: This group will receive Sustained Natural Apophyseal Glide along with Neurodynamics. Patients in this group will receive a baseline treatment that is heating pad for 15 minutes before the treatment.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehsil Headquarter (THQ) hospital khushab
Full name of responsible person
Shehnila shoukat
Street address
House No.4292,Street No.2,MohaAllah Ali Pura Khushab
City
Khushab
Postal code
41000
Phone
+92 454 710161
Email
Shehnila.499@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah international University
Full name of responsible person
Shehnila Shoukat
Street address
House No.4292,Street No.2,MohaAllah Ali Pura Khushab
City
Khushab
Postal code
41000
Phone
+92 454 710161
Email
Shehnila.499@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah international University
Full name of responsible person
Shehnila Shoukat
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House No.4292,Street No.2,MohaAllah Ali Pura Khushab
City
Khushab
Province
Punjab
Postal code
41000
Phone
+92 454 610161
Email
Shehnila.499@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah international University
Full name of responsible person
Shehnila shoukat
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House No.4292,Street No.2,MohaAllah Ali Pura Khushab
City
Khushab
Province
Punjab
Postal code
41000
Phone
+92 454 710161
Email
Shehnila.499@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah international University
Full name of responsible person
Shehnila Shoukat
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House No 4292,Street No.2,Mohallah Ali Pura Khushab
City
Khushab
Province
Punjab
Postal code
41000
Phone
+92 454 710161
Email
Shehnila.499@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The Effect of Sustained Natural Apophyseal Glide with and Without Neurodynamics in the Management of Patient with Cervical Radiculopathy
When the data will become available and for how long
Within 2 months
To whom data/document is available
Online
Under which criteria data/document could be used
By email
From where data/document is obtainable
Tehsil Headquarter (THQ) hospital Khushab
What processes are involved for a request to access data/document
E mail
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